Comparative evaluation of efficacy and safety of cefotaxime-sulbactam with amoxicillin-clavulanic acid in children with lower respiratory tract infections.
OBJECTIVE
Beta-lactamase producing bacteria present a major problem in treating lower respiratory tract infections. The objective of this study was to evaluate efficacy and safety of cefotaxime-sulbactam combination versus amoxicillin-clavulanic acid injection as an alternative therapeutic option for treatment of lower respiratory tract infections in pediatric patients.


METHODS
This randomized, multicentric, comparative study enrolled 102 inpatients with lower respiratory tract infections, in the age range of 3 months - 12 years. Patients received cefotaxime-sulbactam or amoxicillin-clavulanic acid injection intravenously for up to 7 days.


RESULTS
There was no difference between the two groups in demography or disease characteristics (p > 0.05) at baseline. Efficacy was evaluated in a total of 96 patients. Both the treatment groups were comparable in response rate at the end of the therapy (p > 0.05). Clinical success rate was 93.6% and 89.8%, respectively for cefotaxime-sulbactam and co-amoxiclav. One patient from the cefotaxime-sulbactam group reported convulsions, which were probably not related to the study medication in the opinion of the investigator. Except for this serious adverse event, both the study medications were safe and well tolerated in the study population.


CONCLUSIONS
In conclusion, cefotaxime-sulbactam administered 3 times a day for up to 7 days was found to be as effective as co-amoxiclav therapy. However, further studies with a large number of patients are required to confirm these findings with more robust microbiological evaluation.
Pareek
Anil
A
Ipca Laboratories Ltd, Medical Affairs and Clinical Research, 142 AB, Kandivli Industrial Estate, Kandivli (West), Mumbai 400067, India. anilpareek@ipca.co.in
Kulkarni
Madhuri
M
Daga
Subhashchandra
S
Deshpande
Anand
A
Chandurkar
Nitin
N
D019980:Amoxicillin-Potassium Clavulanate Combination / Q000009:adverse effects / Q000627:therapeutic use*; D002439:Cefotaxime / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000473:pathology*; D013407:Sulbactam / Q000009:adverse effects / Q000627:therapeutic use*
D019980:Amoxicillin-Potassium Clavulanate Combination; D002439:Cefotaxime; D013407:Sulbactam